Transvenous Optoacoustic-Ultrasound Guided Cold Laser Wire for Crossing Coronary Chronic Total Occlusion

经静脉光声超声引导冷激光线穿越冠状动脉慢性完全闭塞

• 批准号: 10435198
• 负责人: MARC David FELDMAN
• 金额: $ 63.44万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10435198
• 关键词: Acute; Address; Adipose tissue; Affect; American; Angiography; Animal Model; Anterior Descending Coronary Artery; Arterial Fatty Streak; Arteries; Atherosclerosis; Blood flow; Bypass; Caliber; California; Cardiac; Cardiac Tamponade; Cardiology; Cardiovascular Diseases; Catheters; Cessation of life; Chest Pain; Chronic; Clinic; Complex; Complication; Coronary; Coronary Artery Bypass; Coronary artery; Development; Devices; Discipline; Disease; Dissection; Endothelial Cells; Environment; Event; Failure; Family suidae; Fatigue; Fiber; Frail Elderly; Goals; Health; Heart; Heart Transplantation; Hour; Human; Image; Injury; Institutes; Intervention; Lasers; Left; Left Ventricular Ejection Fraction; Length of Stay; Lesion; Light; Mechanics; Medical; Morbidity - disease rate; Myocardial Infarction; Operative Surgical Procedures; Optics; Organ Transplantation; Outcome; Participant; Patient-Focused Outcomes; Patients; Perforation; Peripheral; Procedures; Program Development; Recovery; Research; Shortness of Breath; Side; Stents; Structure of left gastric vein; Symptoms; System; Techniques; Testing; Therapeutic; Time; Treatment Protocols; Ultrasonography; Universities; Veins; base; calcification; cell injury; cost; design; image guided; imaging system; improved; in vivo; innovation; minimally invasive; mortality; novel; optical fiber; percutaneous coronary intervention; photoacoustic imaging; pressure; randomized controlled study; real-time images; reduce symptoms; research and development; restenosis; safe patient; sound; stent thrombosis; ultrasound

ABSTRACT Coronary chronic total occlusions (CTOs) are atherosclerotic plaques comprised of hard fibro-calcific material that restrict luminal cross-section by 100% resulting in complete stoppage of blood flow in the affected artery for at least three months. CTO symptoms include shortness of breath with chronic fatigue and chest pain. The three primary CTO treatment regimens are medical therapy (MT), coronary artery bypass graft (CABG) and percutaneous coronary interventions (PCI). MT can reduce symptoms such as chest pain but fail to address the underlying disease mechanisms. CABG does provide marked improvements in both patient morbidity and mortality, however, this open-heart surgical intervention is highly invasive, traumatic, expensive and has a limited lifetime. Because most CABG grafts utilize re-purposed veins, 50% become occluded within ten years after bypass surgery. PCI procedures are provided over a 24-hour hospital stay, have one-two days of recovery time and cost approximately one-fourth of CABG yet are currently administered to only 10% of CTO patients. In the most common PCI procedure, subintimal crossing, a mechanical wire is advanced past the CTO inside the vessel wall. Few interventionalists practice subintimal crossing because the procedure is difficult, risky and associated with higher MACE, restenosis, acute MI and death. Although many intravascular devices have been introduced to perform PCI true-lumen CTO crossing, all have failed in the coronary arteries. Failure of these previous devices is due to at least one of three causes: 1) large-diameter catheters that are too rigid with poor steerability; 2) non-specific injury to the vessel wall resulting from CTO cutting; and 3) absence of a navigational guidance system based on real-time imaging of the catheter tip relative to the arterial wall. An optoacoustic (OA) and ultrasound (US) image-guided cold laser wire (CLW) is proposed that provides controlled cutting that will allow any interventional cardiologist to provide patients safe and efficacious PCI true-lumen CTO crossing. Development of the transvenous OA/US image-guided CLW will be accomplished by completing three specific aims: Aim 1: Develop an Optoacoustic (OA)/Ultrasound (US) Transvenous Image-Guided Cold Laser Wire; Aim 2: Test CLW True-Lumen PCI CTO Crossing in ex vivo Human CABG Hearts; Aim 3: Test CLW True-Lumen PCI Crossing of Calcified CTOs in in vivo Animal Models. Successful completion of the proposed research and development program will introduce a true-lumen PCI CTO crossing procedure that when followed by stenting can establish a superior and new treatment paradigm for interventional cardiology and can impact other surgical disciplines.

抽象的 冠状动脉慢性完全闭塞 (CTO) 是由硬纤维钙化物质组成的动脉粥样硬化斑块 100% 限制管腔横截面，导致受影响动脉中的血流完全停止 至少三个月。 CTO 症状包括呼吸短促、慢性疲劳和胸痛。这 三种主要的 CTO 治疗方案是药物治疗 (MT)、冠状动脉旁路移植术 (CABG) 和 经皮冠状动脉介入治疗（PCI）。 MT 可以减轻胸痛等症状，但无法解决 潜在的疾病机制。 CABG 确实显着改善了患者的发病率和 然而，这种直视手术干预具有高度侵入性、创伤性、昂贵且有限的死亡率。 寿命。由于大多数 CABG 移植物使用重新用途的静脉，因此 50% 在移植后十年内发生闭塞 心脏搭桥手术。 PCI 手术在 24 小时住院期间提供，有 1 至 2 天的恢复时间 其费用约为 CABG 的四分之一，但目前只有 10% 的 CTO 患者接受这种治疗。在 最常见的 PCI 手术，内膜下穿越，机械线穿过血管内的 CTO 墙。很少有介入医生进行内膜下穿越，因为该手术困难、风险大且相关性强。 具有较高的 MACE、再狭窄、急性心肌梗死和死亡。尽管已经引入了许多血管内装置 进行PCI真腔CTO穿越，冠状动脉均失败。之前的这些失败 装置的损坏至少是由以下三个原因之一造成的：1）大直径导管过于刚性，可操纵性差； 2）CTO​​切割造成的血管壁非特异性损伤； 3）缺乏导航指导 基于导管尖端相对于动脉壁的实时成像的系统。光声 (OA) 和 提出了超声（美国）图像引导冷激光线（CLW），可提供受控切割，从而允许 任何介入心脏病专家为患者提供安全有效的 PCI 真腔 CTO 穿越。 经静脉 OA/US 图像引导 CLW 的开发将通过完成三个具体任务来完成 目标： 目标 1：开发光声 (OA)/超声 (美国) 经静脉图像引导冷激光 金属丝;目标 2：在离体人 CABG 心脏中测试 CLW True-Lumen PCI CTO Crossing；目标 3：测试 CLW 体内动物模型中钙化 CTO 的真腔 PCI 穿越。圆满完成了 拟议的研发计划将引入真腔 PCI CTO 交叉程序 随后进行支架置入术可以为介入心脏病学建立一种优越的、新的治疗范例 并可能影响其他外科学科。